FDA 510(k)

CRANIOTOME BLADE OR NEURO BLADE

K-Number: K881418 · 1988-05-31

ApplicantNuell Air Equipment & Hospital Supplies, Inc.

Decision Date1988-05-31

Product CodeHBE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

CRANIOTOME BLADE OR NEURO BLADE is the device name listed in this FDA 510(k) record. The listed applicant is Nuell Air Equipment & Hospital Supplies, Inc.. It received FDA 510(k) clearance on 1988-05-31 under 510(k) number K881418. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRANIOTOME BLADE OR NEURO BLADE?

CRANIOTOME BLADE OR NEURO BLADE is a medical device that received FDA 510(k) clearance on 1988-05-31. The listed applicant is Nuell Air Equipment & Hospital Supplies, Inc.. The 510(k) number is K881418.

When did CRANIOTOME BLADE OR NEURO BLADE receive FDA 510(k) clearance?

CRANIOTOME BLADE OR NEURO BLADE received FDA 510(k) clearance on 1988-05-31, under 510(k) number K881418.

Who is the listed applicant for CRANIOTOME BLADE OR NEURO BLADE?

The FDA 510(k) record lists Nuell Air Equipment & Hospital Supplies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRANIOTOME BLADE OR NEURO BLADE?

The FDA product code for CRANIOTOME BLADE OR NEURO BLADE is HBE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.